A Real World Study of Participants With Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) (LuCaRTE)

Characterization of the Population, Treatment Patterns and Outcomes of Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) - Multicenter Retrospective Cohort Study

This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene. The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants (aged greater than or equal to [>=] 18 years) with a histologically or cytologically confirmed diagnosis of NSCLC, unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation.

Description

Inclusion criteria:

• Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022
• Diagnosed and treated at one of the participating study centers within the defined study period

Exclusion criteria:

• Participants who received any systemic cancer treatment outside the participating treatment centers
• Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma
• Participants enrolled in clinical trials during the study period.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLC; Participants with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC), unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation will be included in this cohort. The existing secondary data from electronic health records (EHR) of these participants from approximately five selected Portuguese healthcare sites will be processed. Each participant will be followed up from index date (date on which participant is included in study) up to 31 March 2026 or at censoring, No intervention will be provided as a part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Characteristics: Age	Age in years of the participants will be reported.	Baseline
Sociodemographic Characteristics: Sex	Sex (male, female) of the participants will be reported.	Baseline
Sociodemographic Characteristics: Weight	Weight (in kilograms [kg]) of the participants will be reported.	Baseline
Sociodemographic Characteristics: Smoking Status	Participants smoking status that is current or former smoker will be reported.	Baseline
Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status	ECOG performance status of the participants will be reported.	Baseline
Sociodemographic Characteristics: Disease Histopathology	Number of participants based on disease histopathology will be reported.	Baseline
Sociodemographic Characteristics: Type of Mutation	Number of participants based on type of mutation will be reported.	Baseline
Sociodemographic Characteristics: Disease Stage	Number of participants based on the stage of disease will be reported.	Baseline
Sociodemographic Characteristics: Cancer Metastasis	Number of participants based on cancer metastasis will be reported.	Baseline
EGFR Mutation Prevalence	Number of participants with EGFR mutations will be reported.	Up to approximately 7 years 9 months
Percentage of Participants by Type of Mutation of EGFR	Percentage of participants by type of mutation of EGFR will be reported.	Up to approximately 7 years 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of EGFR Mutations	Frequency of EGFR mutations will be reported.	Up to approximately 7 years 9 months
Number of Participants by Treatment Options	Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported.	Up to approximately 7 years 9 months
Real-World Overall Survival (RW-OS)	RW-OS is defined as time elapsed between index date and date of death from any cause.	Up to approximately 7 years 9 months
Real-World Progression-Free Survival (RW-PFS)	RW-PFS is defined as the time elapsed between the start of a new line of treatment to the date of documented disease progression or death from any cause, whichever occurs first.	Up to approximately 7 years 9 months
RW-PFS from First Line of Treatment (RW-PFS 2)	RW-PFS 2 is defined as the time elapsed between the start of a first line of treatment to the date of documented second disease progression or death from any cause, whichever occurs first.	Up to approximately 7 years 9 months
Real-World Time on Treatment (RW-TOT)	RW-TOT is defined as the time elapsed between the start date of a line of treatment to the date of treatment discontinuation for any reason.	Up to approximately 7 years 9 months
Real-World Time to Next Treatment (RW-TTNT)	RW-TTNT is defined as the time elapsed between the start of a given line of treatment to the initiation of the subsequent line of systemic therapy.	Up to approximately 7 years 9 months
Real-World Overall Response Rate (RW-ORR)	RW-ORR is defined as the percentage of participants whose cancer show partial response or complete response of all target lesions following a specific line of treatment.	Up to approximately 7 years 9 months
Number of Appointments	Number of appointments related to NSCLC by line of treatment such as oncology, pulmonology, primary care, radio-oncology, thoracic surgery, nursing, psychology, nutrition, physiotherapy will be reported.	Up to approximately 7 years 9 months
Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures	Number of participants receiving complementary diagnostic and therapeutic procedures and type of complementary diagnostic and therapeutic procedures received (for example, imaging, laboratory tests, biopsies, radiotherapy sessions, surgery, medication) will be reported.	Up to approximately 7 years 9 months
Number Participants with Emergency Room Visits Related to NSCLC	Number of participants with emergency room visits related to NSCLC will be reported.	Up to approximately 7 years 9 months
Percentage of Participants Hospitalized	Percentage of participants with at least one hospitalization will be reported.	Up to approximately 7 years 9 months
Number of Hospitalizations	Total number of hospitalizations for the participants will be reported.	Up to approximately 7 years 9 months
Median Length of Stay	Median length of stay in days per hospitalization will be reported.	Up to approximately 7 years 9 months
Net Costing	The net cost of different treatment practices per participants will be reported.	Up to approximately 7 years 9 months

Collaborators and Investigators

• Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Investigators: Study Director: Janssen-Cilag Farmaceutica, Lda. Clinical Trial, Janssen-Cilag Farmaceutica, Lda.

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 61186372NSC4016 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No